Implant Direct Legacy Implant Closed-Tray Transfer-Concave Profile — Class II medical device recall Z-0089-2019
Terminated recall by Implant Direct Sybron Manufacturing, LLC, reported 2018-10-17, distributed nationwide. Cap may be mislabeled with incorrect part number, although the correct part number is on the main vial label.
| Recall number | Z-0089-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Implant Direct Sybron Manufacturing, LLC, Thousand Oaks, CA, United States |
| Recall initiated | 2018-05-29 |
| Classified | 2018-10-09 |
| Reported by FDA | 2018-10-17 |
| Terminated | 2020-07-29 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, DE, GB, KW, LT, NL, SK |
| Quantity | 217 units |
| Reason classes | labeling |
| Lot numbers | 90212 |
| Model numbers | 8735-05 |
Product
Implant Direct Legacy Implant Closed-Tray Transfer-Concave Profile, 3.5mmD Platform. Dental implant component, used temporarily during impressions for the prosthetic procedure.
Reason for recall
Cap may be mislabeled with incorrect part number, although the correct part number is on the main vial label.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0089-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.